Oculogica Portable EyeBOX Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy of clinical diagnosis of post-concussion symptoms
研究概览
简要总结
The objective of this study is to assess the accuracy of a portable version of the EyeBOX device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. The utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 67 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide documented informed consent or assent along with guardian consent.
- •Have presented, at any time post injury, for any complaint related to an injury involving either a direct force to the head or a blow to the body that has the potential to transmit a rapid acceleration/deceleration of the head, with or without loss of consciousness, with or without external signs of head injury.
- •Be 5 to 67 years of age, inclusive.
- •Have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications.
排除标准
- •Have penetrating trauma or known skull fracture or intracranial injury.
- •Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- •Any of the following conditions, immediately related to the incident injury: loss of consciousness exceeding 30 minutes or best available Glasgow Coma Scale (GCS) score less than 13 within 24 hours or other acute conditions requiring emergency medical management.
- •Be blind (no light perception), have missing or non-functional eyes.
- •Be unable to open their eyes.
- •Have a history of unresolved strabismus, diplopia, amblyopia.
- •Have a history of unresolved cranial nerve III, IV, or VI palsy.
- •Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
- •Have a history of extensive prior eye surgery or scarring (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions).
- •Have a prior history of unresolved ocular-motor dysfunctions.
- •Be intoxicated.
结局指标
主要结局
Diagnostic accuracy of clinical diagnosis of post-concussion symptoms
时间窗: Up to one year after initial presentation
Sensitivity and Specificity compared to post-concussion symptoms
Diagnostic accuracy of initial clinical diagnosis of concussion
时间窗: Day 0 (when patient first presents for evaluation)
Sensitivity and Specificity compared to the initial diagnosis of concussion
Adverse Events
时间窗: Through study participation, up to one year
Adverse events occurring during use of the diagnostic device
次要结局
- Diagnostic accuracy to identify increases or decreases in post-concussion symptom severity(Up to one year after initial presentation)
- Diagnostic accuracy of initial clinical diagnosis of concussion(Day 0 (when patient first presents for evaluation))
- Subgroup analyses(Up to one year after initial presentation)